The following data is part of a premarket notification filed by Respiratory Care, Inc. with the FDA for Circapak Universal Volume Ventilator Circuit.
| Device ID | K861555 |
| 510k Number | K861555 |
| Device Name: | CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESPIRATORY CARE, INC. 900 W. UNIVERSITY Arlington Heights, IL 60004 |
| Contact | Wilke |
| Correspondent | Wilke RESPIRATORY CARE, INC. 900 W. UNIVERSITY Arlington Heights, IL 60004 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-25 |
| Decision Date | 1986-06-05 |